BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3

    K Number: K800296 · Decision Mar 5, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    14
    Applicant Total
    44
    Review Days
    23

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    Basic Information

    Device Name
    WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3
    K Number
    K800296
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Dade, Baxter Travenol Diagnostics, Inc.
    Date Received
    February 11, 1980
    Decision Date
    March 5, 1980
    Product Code
    GGM
    Advisory Committee
    Hematology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GGM Control, Hemoglobin

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    K792443 TSH RADIOIMMUNOASSAY
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    K791922 HARLECO BRAND CLINICARD LIPASE TEST SET
    K792183 DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO
    K790767 IMMU-TEK AUTOMATIC CENTRIFUGE
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